6/5/2023 0 Comments Iso 13485 complianceThe top 11 errors in computer system validation.Why validation makes good business sense.What I have to validate to meet FDA and ISO 13485 requirements.Emphasis is placed on applications currently used in production and quality systems, such as document control, ERP, complaint, and QA systems, and manufacturing execution systems. This presentation will review the FDA and ISO requirements for computer system validation and describe methods for meeting those requirements. Medical device companies must transition to the 2003 version of 13485.
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